Recon: FDA Warns of Severe Worsening of MS After Stopping Gilenya; EC Signs Off on Takeda Acquisition of Shire

Regulatory NewsRegulatory News | 21 November 2018 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Step off our 'donut hole' deal: AARP ads take on Big Pharma lobbying (Fierce)
  • US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein (Pink Sheet-$)
  • FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (FDA)
  • Apple in Talks to Give Veterans Access to Electronic Medical Records (WSJ-$)
  • Walgreens, Humana Are in Preliminary Talks to Take Stakes in Each Other (WSJ-$)
  • FDA Chief Says Higher Prices Could Cure Drug Shortages (Bloomberg)
  • The Bernie Sanders-Trump mind meld on drug costs (Politico)
  • Drug companies snub Trump by hiking prices (Fox Business)
  • Pfizer wants to reel back contributions to Hyde-Smith (Endpoints) (Washington Examiner)
In Focus: International
  • EU regulators approve Takeda’s acquisition of Shire after divestment (European Commission) (In-PharmaTechnologist) (Law360-$)
  • Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications (EMA)
  • BASF unveils major restructuring (C&EN)
  • GSK retains leading position on access to medicines list (PharmaTimes)
  • UK Providers Seek More Real-World Evidence, Financial Incentives for Biosimilar Use (Center for Biosimilars)
  • Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration (TGA)
  • Further guidance on producing and distributing effective field safety notices from medical devices (MHRA)
Pharmaceuticals & Biotechnology
  • Pharma companies put faith in AI for breakthroughs (Financial Times-$)
  • Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about Others (FDA Law Blog)
  • Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets (FDA)
  • Dr. Reddy’s, Mylan Win Challenge To Arthritis Drug Patents (Law360-$)
  • Fed. Circ. Lifts Block On Dr. Reddy's Suboxone Generic (Law360-$)
  • Former Teva Exec Nabs $6.2M Bias Verdict After Firing (Law360-$)
  • Court Denies Judgment on the Pleadings in Amgen v. Mylan (Big Molecule Watch Blog)
  • Idorsia sheds surplus DMD therapy to Santhera (Fierce)
  • Biogen tasks HitGen with discovering neurological leads (Fierce)
  • Rentschler opens GMP fill/finish facility in Austria (BioPharma-Reporter)
  • Jury finds former Aveo CFO David Johnston guilty of scheme to mislead investors (Endpoints)
  • Who are the best — and worst — among the major pharmas at developing drugs for the poor? (Endpoints)
  • Roche ties up again with Ascletis — this time on a commercial partnership for hep B drug (Endpoints)
  • Clozel hands over a rival to PTC’s controversial steroid deflazacort (Endpoints)
  • Astellas launches Global Health Foundation (PharmaLetter-$)
  • LEO Pharma and PellePharm Announce $760 Million Collaboration to Advance Innovative Therapies for Rare Skin Diseases (Press)
  • Ligand Announces OmniAb Partnership with iMetabolic Biopharma Corporation (Press)
Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations
  • Protecting the Value of Medical Science in the Age of Social Media and “Fake News” (JAMA)
  • Expanded Access Data Can Support Approval Decisions, US FDA Says (Pink Sheet-$)
  • Estimation of global insulin use for type 2 diabetes, 2018–30: a microsimulation analysis (Lancet)
  • Study: Biosimilar Filgrastim Use Is Concordant With EORTC Guidelines (Center for Biosimilars)
  • Allergan Announces FDA Acceptance of Supplemental New Drug Application for AVYCAZ (Press)
  • Stemline Therapeutics Announces that European Medicines Agency (EMA) Grants Accelerated Assessment for planned ELZONRIS Marketing Authorization Application (Press)
Medical Devices
  • FDA plans to convene an advisory committee meeting to share the available evidence and seek expert opinion about the safety and effectiveness of surgical mesh (FDA)
  • Recall: Beckman Coulter Life Sciences Recalls FC 500 and the EPICS XL Series Flow Cytometers Due to Risk of Inaccurate Results (FDA)
  • Insulet’s Omnipod Dash system lands ISO cert for data security (DrugDelivery)
  • Guidance on the regulation of menstrual cups in Australia (TGA)
US: Assorted & Government
  • FDA's Woodcock: 'The clinical trial system is broken' (BiopharmaDive)
  • Lawyer: Key Questions Linger With FDA’s New Drug Software Framework (InsideHealthPolicy-$)
  • CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests (FDA)
  • Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Second Quarter of 2018 (HHS OIG)
  • Trump admin reapproves Kentucky's Medicaid work requirement waivers (Politico)
  • Acthar Proposed Giveaway Program Raises Kickback Concerns, OIG Says (Pink Sheet-$)
  • Antitrust in the Pharmaceutical Sector: An Overview of U.S. Case Law (SSRN)
  • FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder (FDA)
Upcoming Meetings & Events General Health & Other Interesting Articles
  • Romaine lettuce is not safe to eat, CDC warns U.S. consumers (Washington Post)
  • Why Don’t We Have Vaccines Against Everything? (NY Times-$)
  • Scientists are trying to create a contraceptive that stops sperm in its tracks (Stat)
  • Google Taking Over Health Records Raises Patient Privacy Fears (Bloomberg)
  • BioMarin Sponsors Off-Broadway Show About Hemophilia (Reuters) (BioSpace)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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